Priority New Monograph Items

USP seeks sponsors to aid in developing the following list of monographs that are not part of the official USP-NF.  The list contains drug substance, drug product, and excipient monographs.  We may accept any qualified sponsor for a monograph estimated to make generic market entry within 5 years.  We will work exclusively with approved manufacturers on monographs expected to make generic market entry in more than 5 years.  These articles have been approved by the FDA and are published in the Approved Drug Products with Therapeutic Equivalence (Orange Book).

Consult the missing monograph list here: 
If you are interested in becoming a product sponsor, contact Michael Goede, Senior Standards Acquisition Manager, at

Helpful Links

For more on the monograph submission process, see USP’s Monograph Submission Guidelines.
Visit the Donor Submission Portal to register and e-file your submission.